MSCS in BURSTDR Patients

Sponsor
Jessa Hospital
Study ID
NCT07540663
Status
Enrolling By Invitation

Conditions

  • FBSS
  • Neuropathic Pain
  • PSPSII

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • muscle simulation — OTHER
    patients will be programmed in a tonic low frequency program which they will use 2x a day for 30 minutes besides their regular stimulation

Study Details

The patients included in this study have already undergone the process of probe implantation and adjustment to their individually suitable stimulation pattern. Patients will be selected if the probe was implanted 0 - 5 years ago. Patients with implanted percutaneous electrodes (octrodes) and plate electrodes (surgical lead group) will be included in the study. The aim of this study is to investigate whether additional muscle stimulation can optimize the current pain therapy. After being informed about the study and providing informed consent, the questionnaires (baseline) are completed before the start of the study. Then, in addition to the existing BurstDR stimulation, additional muscle stimulation is started twice a day for 30 minutes and continued for 3 months. During this time, the pain values are also determined every 4 weeks using the visual analog scale (VAS), Oswestry Disabillity Index (ODI), EQ5D-5L, Pain Catastrophizing Scale (PCS), Pain Disability Index (PDI), Patient Global Impression of Change (PGIC). At the end of 3 months, the questionnaires are completed again. The VAS values and the values from the questionnaires are compared with the baseline values. In addition, possible side effects and adverse reactions that could be triggered by the stimulation are recorded at this time. This study makes it possible to investigate the combination of pain treatment with BurstDR and simultaneous muscle stimulation with an Octrodes and pentaleads for chronic back pain in a prospective study.

Key Dates

First listed
Apr 20, 2026
Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Mar 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: active additional program arm
    active additional stimulation on regular stimulation settings

Primary Outcome Measure

visual Analogue SCALE (VAS) [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]

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